The Gender Inclusive Sexuality Talks Program

NCT07825571 | Recruiting

• 1 other identifier: 24-0991 (856181)
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study is centered on helping parents answer and meet the sexuality-specific questions and needs of transgender, gender diverse, lesbian or bisexual female youth. This study seeks to test the efficacy of the GIST Program as a parent-child sexuality communication intervention that educates and trains parents to be purveyors of inclusive health information as transgender, gender diverse, lesbian or bisexual female youth come of age at home.

Conditions

HIV/STI Incidence; Communication About Health Information

Outcome Measures

Primary Outcomes (2)

• Parent-Adolescent Communication Quantity

  The Parent- Teen Sexual Risk Communication Topic Scale will be adopted and used to measure the quantity of topics discussed. Participants are asked if they had ever discussed the topics with their child/parent, and if so, which ones. To measure quantity, sample questions would be "To what extent have you ever discussed any of the following topics with your mother/father?" Sample items: coming out/disclosure of sexual orientation, using a condom, peer pressure and sexual pressure from dating partners, penilevaginal or other types of intercourse. Response options: (1) none, (2) a little, (3) some, (4) a lot, or (5) extensive. (8 items; alpha = .85-.95)

  Baseline, 1 week, 3 months, 6 months

• Parent-Adolescent Communication Quality

  The quality of sexuality-sensitive communication will be determined using the Family Sexuality Communication Quotient - a measure of a general family orientation to discussion about sexuality between parents and children; this is an 18-item scale with options (1-Strongly Agree to 5-Strongly Disagree). The first subscale on comfort measures the perceived degree of openness with which sexuality is discussed in the family (e.g., I feel free to ask my parents questions about sexuality). The second subscale on information measures perception of the amount of information learned and shared during discussions (e.g., I feel better informed about sexuality if I talk to my parents.) (18 items; alpha = .91)

  Baseline, 1 week, 3 months, 6 months

Secondary Outcomes (4)

• Adolescent and Parent Mental Health (Depression)

  Baseline, 1 week, 3 months, 6 months

• Adolescent and Parent Mental Health (Anxiety)

  Baseline, 1 week, 3 months, 6 months

• Parent-Adolescent Health Behavior (Wellness Appointment)

  Baseline, 1 week, 3 months, 6 months

• Family Functioning

  Baseline, 1 week, 3 months, 6 months

Study Arms (2)

GIST Intervention Arm

EXPERIMENTAL

Parents randomized to this arm will receive five, online based group sessions.

Behavioral: The Gender Inclusive Sexuality Talks Program

Control Arm

ACTIVE COMPARATOR

Parents randomized to this arm will have individual access to an online series of five modules that they can complete at their own pace. The content for each module are LGBTQ-specific health issues such as sleep hygiene, bullying, tobacco and alcohol use, and body image concerns.

Behavioral: GIST Control

Interventions

The Gender Inclusive Sexuality Talks Program BEHAVIORAL

The GIST Program is a 5-session intervention where an interventionist will facilitate sessions that will include 8-12 parents per group. Each parent will have access to intervention content (e.g., videos, activities) across five synchronous sessions. Session I will focus on the issue of coming out and its impact on the family as well as on youth mental health. Session II centers on communication-based content. Sessions III and IV focuses on topic-centered content to address the knowledge gap parents have reported regarding general LGBTQ concerns and builds on the communication skills learned in Session I. Session V provides a communication recap and focuses on how parents may have follow-up conversations with healthcare providers. In between the sessions, asynchronous interactive homework assignments will be provided to review concepts learned in the previous sessions and to initiate joint activities between parents and youth.

GIST Intervention Arm

GIST Control BEHAVIORAL

The control arm consists of access to five online modules. Parents in this condition will be able to view video content focused on health issues germane for LGBTQ youth that are not focused on sexual health. These outcomes are on bullying, alcohol and tobacco use, sleep hygiene and body image concerns.

Control Arm

Eligibility Criteria

• Age: 12 Years - 100 Years
• Gender Eligibility Details: Index youth are eligible if they are transgender or gender diverse, or if they identify as lesbian or bisexual female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Youth participants are:
• identify as transgender or gender diverse, or lebian or bisexual female be between ages 12-18 years able to comprehend spoken English resides in the United States consents or assents to study participation
• Parent participants are:
• the parent, legal guardians, legal custodians (hereinafter "parent") of index youth age 18 or older able to comprehend spoken English resides in the United States consents to study participation consents to their child's study participation

You may not qualify if:

• Excluded youth participants are:
• non-transgender or gender diverse or lesbian or bisexual female youth
• Excluded participants are:
• parents whose child does not meet eligibility criteria

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Nursing

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

• Flores DD, Rosario AA, Bond KT, Villarruel AM, Bauermeister JA. Parents ASSIST (Advancing Supportive and Sexuality-Inclusive Sex Talks): Iterative Development of a Sex Communication Video Series for Parents of Gay, Bisexual, and Queer Male Adolescents. J Fam Nurs. 2020 May;26(2):90-101. doi: 10.1177/1074840719897905. Epub 2020 Jan 31.

  PMID: 32003286 BACKGROUND

• Flores DD, Hennessy K, Rosario A, Chung J, Wood S, Kershaw T, Villarruel A, Bauermeister J. Parents ASSIST: Acceptability and Feasibility of a Video-Based Educational Series for Sexuality-Inclusive Communication between Parents and Gay, Bisexual, and Queer Sons. Int J Environ Res Public Health. 2021 Dec 30;19(1):379. doi: 10.3390/ijerph19010379.

  PMID: 35010638 BACKGROUND

Study Officials

• Dalmacio D Flores

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalmacio Flores, PhD, RN

CONTACT

215-573-8253; dalmacio@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Each parent will receive both study conditions: (1) the intervention workshop and (2) control videos, with sequencing order of the two arms randomized. Following completion of participation in a study arm, there will be a 4-week washout, which is sufficient to assess short-term retention while minimizing contamination across conditions.

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)